[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622887":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":44,"centralContacts":45,"locations":55,"responsibleParty":195,"collaborators":197,"id":203,"slug":204,"hasResults":205,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":44,"eligibilityCriteria":209,"healthyVolunteers":205,"sex":210,"minAge":211,"maxAge":44,"enrollmentInfo":212,"targetDuration":44,"studyType":215,"phases":216,"briefSummary":218,"conditions":219,"keywords":221,"overallStatus":227,"whyStopped":44,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":237},{"fullName":5,"class":6},"First Affiliated Hospital Xi'an Jiaotong University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"rhPro-UK group","EXPERIMENTAL","Patients in this group will be treated with intravenous rhPro-UK and endovascular thrombectomy",[13,14],"Drug: Intravenous rhPro-UK","Procedure: Endovascular thrombectomy",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo group","PLACEBO_COMPARATOR","Patients in this group will be treated with intravenous placebo and endovascular thrombectomy",[20,14],"Drug: Intravenous placebo",[22,30,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Intravenous rhPro-UK","Patients will receive intravenous rhPro-UK",[9],[28,29],"Intravenous PUK","Intravenous recombinant human prourokinase",{"type":23,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Intravenous placebo","Patients will receive intravenous placebo",[16],[35],"Intravenous placebo (a visually identical substance without pharmacological activity)",{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"PROCEDURE","Endovascular thrombectomy","Patients will receive endovascular thrombectomy",[16,9],[42,43],"Endovascular treatment","Mechanical thrombectomy",null,[46,51],{"name":47,"role":48,"phone":49,"phoneExt":44,"email":50},"Fude Liu, MD","CONTACT","18161823657","liufude101@163.com",{"name":52,"role":48,"phone":53,"phoneExt":44,"email":54},"Yawen Cheng, MD","13572255252","alicia_cheng@126.com",[56,73,87,101,115,129,143,154,168,182],{"facility":57,"status":44,"city":58,"state":59,"zip":44,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"The First Hospital of Lanzhou University","Lanzhou","Gansu","China","CN",{"type":63,"coordinates":64},"Point",[65,66],103.83987,36.05701,{"lat":66,"lon":65},[69],{"name":70,"role":48,"phone":71,"phoneExt":44,"email":72},"Youquan Gu, MD","139909406189","guyq@lzu.edu.cn",{"facility":74,"status":44,"city":75,"state":76,"zip":44,"country":60,"countryCode":61,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"The Third Hospital of Hebei Medical University","Shijiazhuang","Hebei",{"type":63,"coordinates":78},[79,80],114.47861,38.04139,{"lat":80,"lon":79},[83],{"name":84,"role":48,"phone":85,"phoneExt":44,"email":86},"Pinyuan Zhang, MD","15028195377","zhpy_76@sina.com",{"facility":88,"status":44,"city":89,"state":90,"zip":44,"country":60,"countryCode":61,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Henan Provincial People's Hospital","Zhengzhou","Henan",{"type":63,"coordinates":92},[93,94],113.64861,34.75778,{"lat":94,"lon":93},[97],{"name":98,"role":48,"phone":99,"phoneExt":44,"email":100},"Liangfu Zhu, MD","13598881630","sumslfzhu@163.com",{"facility":102,"status":44,"city":103,"state":104,"zip":44,"country":60,"countryCode":61,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Loudi Central Hospital","Loudi","Hunan",{"type":63,"coordinates":106},[107,108],111.99444,27.73444,{"lat":108,"lon":107},[111],{"name":112,"role":48,"phone":113,"phoneExt":44,"email":114},"Cunliang Zhu, MD","18773882121","1722291995@qq.com",{"facility":116,"status":44,"city":117,"state":118,"zip":44,"country":60,"countryCode":61,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"The Second Hospital of Dalian Medical University","Dalian","Liaoning",{"type":63,"coordinates":120},[121,122],121.60222,38.91222,{"lat":122,"lon":121},[125],{"name":126,"role":48,"phone":127,"phoneExt":44,"email":128},"Linyun Zhang, MD","15940850119","zly542644190@163.com",{"facility":130,"status":44,"city":131,"state":132,"zip":44,"country":60,"countryCode":61,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Qinghai Provincial People's Hospital","Xining","Qinghai",{"type":63,"coordinates":134},[135,136],101.75739,36.62554,{"lat":136,"lon":135},[139],{"name":140,"role":48,"phone":141,"phoneExt":44,"email":142},"Yancheng Lei, MD","15897188925","leiyancheng7566@163.com",{"facility":144,"status":44,"city":145,"state":146,"zip":44,"country":60,"countryCode":61,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"First Affiliated Hospital of Xi'an Jiaotong University","Xi'an","Shaanxi",{"type":63,"coordinates":148},[149,150],108.92861,34.25833,{"lat":150,"lon":149},[153],{"name":47,"role":48,"phone":49,"phoneExt":44,"email":50},{"facility":155,"status":44,"city":156,"state":157,"zip":44,"country":60,"countryCode":61,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Shanxi Cardiovascular Hospital","Taiyuan","Shanxi",{"type":63,"coordinates":159},[160,161],112.56028,37.86944,{"lat":161,"lon":160},[164],{"name":165,"role":48,"phone":166,"phoneExt":44,"email":167},"Weirong Li, MD","18735133366","weironglee@163.com",{"facility":169,"status":44,"city":170,"state":171,"zip":44,"country":60,"countryCode":61,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"The First Affiliated Hospital of Shihezi University","Shihezi","Xinjiang Uygur Autonomous Region",{"type":63,"coordinates":173},[174,175],86.03694,44.3023,{"lat":175,"lon":174},[178],{"name":179,"role":48,"phone":180,"phoneExt":44,"email":181},"Linzhi Dai, MD","13677542691","1805308040@qq.com",{"facility":183,"status":44,"city":184,"state":44,"zip":44,"country":60,"countryCode":61,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"Xuanwu Hospital Capital Medical University","Beijing",{"type":63,"coordinates":186},[187,188],116.39723,39.9075,{"lat":188,"lon":187},[191],{"name":192,"role":48,"phone":193,"phoneExt":44,"email":194},"Chuanjie Wu, MD","18911366882","wuchuanjie@xwhosp.org",{"type":196,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR",[198,201],{"name":199,"class":200},"Tasly Pharmaceutical Group Co., Ltd","INDUSTRY",{"name":202,"class":6},"Peking Union Medical College Hospital","100622887","phase-3-intravenous-rhpro-uk-before-stroke-thrombectomy-in-the-extended-time-window-bridge-puk-extend-100622887",false,"NCT07389460","Intravenous rhPro-UK Before Stroke Thrombectomy in the Extended Time Window (BRIDGE-PUK EXTEND)","Intravenous rhPro-UK Versus Placebo Before Endovascular Thrombectomy For Stroke Patient With Large Vessel Occlusion In The Extended Time Window: the Randomized, Placebo-controlled, Double-blind Trial (BRIDGE-PUK EXTEND )","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Acute ischemic stroke presenting within 4.5-24 hours of last known well;\n3. No significant pre-stroke functional disability: for age \\\u003C80 years, pre-stroke modified Rankin scale (mRS) ≤2; for age ≥80 years, prestroke mRS ≤1;\n4. Baseline NIHSS score ≥6;\n5. Imaging criteria of BOTH:\n\n1\\. Occlusion on CTA\u002FMRA in one of the following vessels: M1\u002FM2 segment of middle cerebral artery, A1 segment of anterior cerebral artery, V4 segment of vertebral artery, basilar artery, or P1 segment of posterior cerebral artery. For A1, or P1 occlusions, vessel diameter must be ≥0.75 mm; 2. For anterior circulation occlusion: CTP\u002FMRP demonstrating mismatch ratio ≥1.8, absolute mismatch volume ≥15 mL, and ischemic core volume \\\u003C70 mL; OR have a mismatch between the presence of an abnormal signal on MRI diffusion-weighted imaging and no visible signal change on FLAIR. For posterior circulation occlusion: pc-ASPECTS score ≥6.\n\n6\\. Plan to received endovascular thrombectomy; 7. The patient or their legal representative provides written informed consent.\n\nExclusion Criteria:\n\n1. Intracranial hemorrhage confirmed by CT\u002FMRI;\n2. Onset accompanied by epileptic seizures, resulting in questionable stroke diagnosis and inability to obtain an accurate baseline NIHSS score;\n3. Women who are pregnant or breastfeeding, or have a positive serum β-HCG test upon admission;\n4. Already received intravenous thrombolytic after index stroke;\n5. History of prior intracranial hemorrhage, including cerebral parenchymal hemorrhage, subarachnoid hemorrhage, and subdural\u002Fextradural hematoma;\n6. Active bleeding or bleeding tendency, such as gastrointestinal bleeding, urinary tract bleeding, retinal hemorrhage, etc., or presence of coagulation dysfunction;\n7. History of major recent surgery or trauma, such as intracranial or spinal surgery within the past 3 months, major surgery within the past 2 weeks, or severe head trauma within the past 3 weeks;\n8. Baseline blood glucose \\\u003C2.8 mmol\u002FL or \\>22.2 mmol\u002FL;\n9. Received low molecular weight heparin within 24 hours, or oral anticoagulants with an International Normalized Ratio (INR) \\>1.7, or thrombin inhibitors within 48 hours, among others;\n10. Arterial tortuosity or other vascular anomalies precluding endovascular access to target vessel;\n11. Pre-existing neurological\u002Fpsychiatric disorders interfering with neurological assessment;\n12. Space-occupying intracranial tumors (except for small meningiomas);\n13. Intracranial aneurysm or arteriovenous malformation;\n14. Terminal illness with life expectancy \\\u003C6 months;\n15. Concurrent participation in other investigation clinical trials;\n16. Presence of other conditions deemed by the investigator as unsuitable for participation in the study.","ALL","18 Years",{"count":213,"type":214},820,"ESTIMATED","INTERVENTIONAL",[217],"PHASE3","This randomized, double-blind, placebo-controlled phase III clinical trial aims to evaluate the efficacy and safety of intravenous recombinant human Prourokinase (rhPro-UK) in acute ischemic stroke patients with large vessel occlusion presenting 4.5-24 hours after last known well. The study will address two primary questions: 1) Whether rhPro-UK enhances pre-thrombectomy reperfusion rates and improves 90-day functional outcomes compared to placebo; 2) Whether rhPro-UK increases the risk of symptomatic intracranial hemorrhage and mortality.\n\nParticipants will be randomized to receive an intravenous bolus of rhPro-UK or matching placebo, with a total dose of 35mg (15mg administered as an intravenous push within 5 minutes, and the remaining 20mg continuously infused intravenously over 30 minutes). Key assessments include repeat neuroimaging (CT\u002FCTA or MRI\u002FMRA) at 24 hours post-treatment to evaluate reperfusion, NIH Stroke Scale score at day 5-7, and modified Rankin Scale score assessment at 90 days. Safety monitoring will focus on hemorrhagic transformation and mortality events throughout the study period.",[220],"Acute Ischemic Stroke",[222,223,224,225,226],"Large Vessel Occlusion Stroke","Recombinant Human Prourokinase","Extended Time Window","Intravenous Thrombolytic Therapy","Endovascular Treatment","NOT_YET_RECRUITING","2026-02-04",{"date":230,"type":231},"2026-02-05","ACTUAL",{"date":233,"type":214},"2026-01-31",{"date":235,"type":214},"2028-03-31",{"name":5,"class":6},10]